Human Subjects Research Act Article 12

Where the research subjects are other than a fetus or corpse, such subjects shall consist only of adults capable of communication. However, where the research obviously benefit specific groups or the subjects are irreplaceable, is not subjected to this rule.Research protocol shall obtain the consent of participating research subjects as approved by the IRB. But the research protocol within the scope of exemption categories for consent requirements, as announced by the competent authority, shall not apply.Where the research subject is a fetus, the consent specified in the first Paragraph shall be obtained from the mother; where the subject has been judicially declared to be of limited legal capacity or under assistance, consent shall be obtained from both the individual and their legal representative or assistant; where the person is incompetent or under guardianship, consent shall be obtained from their legal representative or guardian; where the proviso in the first Paragraph is applicable, consent shall be obtained in the following order of precedence from an appropriate relation:1. A spouse2. An adult child3. Parents4. Siblings5. GrandparentsWhere the consent is provided in writing by a relation pursuant to the preceding Paragraph, such written consent may be sufficient where obtained from any such individual; where the express intent of such persons is not unanimous, the order of precedence above shall apply to determine the matter. In the preceding order of precedence, among the same order, closer relatives shall be accorded priority; where the relatives are of the same degree of closeness, cohabitation shall be accorded priority; and in case of non-cohabiting relatives, the elderly shall be accorded priority.